Download IDENTIFYING ATRIAL FIBRILLATION WITH LONG

IDENTIFYING
ATRIAL FIBRILLATION
WITH LONG-TERM
CARDIAC MONITORING:
Reveal LINQ
TM
Insertable Cardiac Monitoring System
HELPING TO PREVENT RECURRENT STROKE
IN CRYPTOGENIC STROKE PATIENTS
Each year,
ABOUT CRYPTOGENIC STROKE1-7
795,000 AMERICANS
experience a stroke.
n
1
n
n
n
~610,000
~185,000
are new strokes are recurrent strokes
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E
ach year, approximately 795,000 Americans
experience a stroke—610,000 of which
are first events and 185,000 of which are
recurrent stroke events.1
In 2011, stroke caused roughly one of every
20 deaths in the United States.1
T
he most common type of stroke is called
an “ischemic stroke,” which affects about
690,000 Americans annually and is a result of
an obstruction within a blood vessel supplying
blood to the brain.1
If the cause of an ischemic stroke cannot be
determined, the stroke is called “cryptogenic,” or
a stroke of unknown cause.
Cryptogenic
strokes account for
approximately 20 to 40 percent of ischemic
strokes in the majority of modern stroke
registries and databases.1-7
ABOUT ATRIAL FIBRILLATION8
n
n
A
trial fibrillation (also known as AF or “a-fib”) is a common cardiac condition defined by irregular or rapid heartbeats.
Failure to recognize and treat AF can lead to strokes as patients with AF are five times more likely to have a stroke.
ABOUT CONTINUOUS, LONG-TERM CARDIAC MONITORING
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U
ndiagnosed AF is believed to be responsible for a significant portion of cryptogenic strokes.1-7
H
owever, because AF often has no symptoms and may occur infrequently, it may not be detected by
conventional monitoring techniques such as in-hospital monitoring, electrocardiography, or traditional
ambulatory cardiac monitors (e.g., Holter).9-12
U
nlike conventional monitoring methods, continuous, long-term cardiac monitoring devices, such as the
Reveal LINQ™ Insertable Cardiac Monitor (ICM), automatically and continuously detect and record abnormal
heart rhythms for up to three years.13
D
etecting AF allows physicians to change a patient’s medical therapy (e.g., from anti-platelet to oral
anticoagulation per guidelines) to potentially help reduce his/her risk of having a second stroke.14-15
SUPPORTING EVIDENCE
n
n
T
he CRYSTAL AF (CRYptogenic STroke And
underLying Atrial Fibrillation) study, published in
The New England Journal of Medicine, found
that continuous cardiac monitoring with the
Reveal™ ICM was superior to standard care
(SoC) at detecting AF in patients who had a
cryptogenic stroke, detecting AF at a rate
seven times higher than SoC monitoring at
12 months.16
A
study presented at the American Heart
Association’s 2015 International Stroke
Conference found that the Reveal LINQ ICM
detected AF in everyday clinical practice at a
much higher rate (37 percent relative increase)
than was found in the CRYSTAL AF study,
suggesting that AF may go undetected at an
even greater rate than previously thought.17
8.8X
CRYSTAL-AF study results
Detection of Atrial Fibrillation by 36 months
Hazard ratio, 8.8 (95% CI, 3.5 - 22.2)
P < 0.001 by log-rank test
30
Atrial Fibrillation Detected
(% of patients)
n
more AF
detected
8.8X
30%
Reveal ICM
20
7.3X
6.4X
12.4%
10
8.9%
1.4%
0
0
6
Control
2%
12
18
24
3%
30
36
Months since randomization
# at risk
Control 220
194
167
114
72
36
ICM 221
191 long-term
173 cardiac
102 monitoring
57
A
separate new analysis presented at the same meeting demonstrated
that
is a 29
7
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cost-effective method of detecting AF in cryptogenic stroke patients to potentially prevent a recurrent stroke.18
n
Research
presented at the 2016 American Academy of Neurology Annual Meeting showed that in a real-world
population of cryptogenic stroke patients, 72 percent of AF patients would have gone undiagnosed if cardiac
monitoring had been limited to 30 days.19
ABOUT THE MEDTRONIC REVEAL LINQ™ ICM SYSTEM
n
n
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Cleared
by the U.S. Food & Drug Administration (FDA) in February 2014, the Reveal LINQ ICM
is the newest generation Reveal ICM and the smallest cardiac monitor available (~1 cc, or
one-third the size of a AAA battery).
C
ommon uses include monitoring syncope patients for potential episodes of bradycardia/asystole,
monitoring cryptogenic stroke patients for possible episodes of AF, and monitoring
patients suffering from intermittent chest palpitations for potential episodes of atrial or
ventricular arrhythmias.
T
he Reveal LINQ ICM is placed under the skin of the chest, and its battery allows for up to three years of monitoring.13
Additionally, the device communicates wirelessly with a patient bedside monitor that uploads device data to the
Medtronic CareLink™ network.
The Reveal LINQ ICM continuously
records heart rhythm data and sends
them wirelessly to the MyCareLinkTM
Patient Monitor.
The MyCareLink Patient Monitor
transmits data from the Reveal
LINQ ICM to the clinic via a global
cellular connection.
The clinic receives easy-to-use
and clinically actionable
Reveal LINQ reports via the
CareLinkTM Network.
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19.
Heart Disease and Stroke Statistics 2015 Update Circulation. 2015; 131:
e29-e322 Published online before print December 17, 2014, doi: 10.1161/
CIR.0000000000000152
Sacco RL, Ellenberg JH, Mohr JP, et al. Infarcts of undetermined cause: the
NINCDS Stroke Data Bank. Ann Neurol. 1989;25:382-390.
Petty GW, Brown RD, Jr., Whisnant JP, et al. Ischemic stroke subtypes: a
population-based study of incidence and risk factors. Stroke. 1999;30:
2513-2516.
Kolominsky-Rabas PL, Weber M, Gefeller O, et al. Epidemiology of ischemic
stroke subtypes according to TOAST criteria: incidence, recurrence and
long-term survival in ischemic stroke subtypes: a population-based study.
Stroke. 2001;32:2735-2740.
Schulz UG, Rothwell PM. Differences in vascular risk factors between
etiological subtypes of ischemic stroke: importance of population-based
studies. Stroke. 2003;34:2050-2059.
Schneider AT, Kissela B, Woo D, et al. Ischemic stroke subtypes: a
population-based study of incidence rates among blacks and whites. Stroke.
2004;35:1552-1556.
Lee BI, Nam HS, Heo JH, et al. Yonsei Stroke Registry. Analysis of 1,000
patients with acute cerebral infarctions. Cerebrovasc Dis. 2001; 12:145-151.
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor
for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8.
Healey JS, Connolly SJ, Gold MR, et al. Subclinical atrial fibrillation and the risk
of stroke. N Engl J Med. 2012;366:120-129.
Seet RC, Friedman PA, Rabinstein AA. Prolonged rhythm monitoring for the
detection of occult paroxysmal atrial fibrillation in ischemic stroke of unknown
cause. Circulation. 2011;124:477-486.
Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus
intermittent monitoring of atrial arrhythmias. Heart Rhythm. 2006;3:
1445-1452.
Ziegler PD, Glotzer TV, Daoud EG, et al. Detection of previously
undiagnosed atrial fibrillation in patients with stroke risk factors and
usefulness of continuous monitoring in primary stroke prevention.
Am J Cardiol.2012;110:1309-1314.
Refer to the Reveal LINQ ICM Clinician Manual for usage parameters.
Jauch EC, Saver JL, Adams HP, Jr., et al. Guidelines for the early management
of patients with acute ischemic stroke: a guideline for healthcare
professionals from the American Heart Association/American Stroke
Association. Stroke. 2013;44:870-947.
Camm AJ, Lip GY, De Caterina R, et al. 2012 focused update of the ESC
Guidelines for the management of atrial fibrillation: an update of the 2010
ESC Guidelines for the management of atrial fibrillation—developed with the
special contribution of the European Heart Rhythm Association. Europace.
2012;14:1385-1413.
Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying
atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/
NEJMoa1313600.
Richards M, Ferreira SW, Nichols A, et al. Incidence and duration of atrial
fibrillation among a large, real-world population of cryptogenic stroke
patients with insertable cardiac monitors. Oral session presented at:
American Stroke Association’s International Stroke Conference 2015; 2015
Feb 11-13; Nashville, TN.
Diamantopoulos A, Sawyer L, Lip GYH, et al. Cost-effectiveness analysis
of an insertable cardiac monitor (ICM) to detect atrial fibrillation in patients
with cryptogenic stroke. Oral session presented at: American Stroke
Association’s International Stroke Conference 2015; 2015 Feb 11-13;
Nashville, TN.
Rogers J, Nichols A, Richards M, et al. Incidence of Atrial Fibrillation Within
One Year of Cryptogenic Stroke Among a Large, Real-World Population with
Insertable Cardiac Monitors. Abstract presented at: American Academy of
Neurology’s Annual Meeting; 2016 April 16-20; Vancouver, BC, Canada.
Brief Statement
Indications
Reveal LINQTM LNQ11 Insertable Cardiac Monitor and Patient Assistant
The Reveal LINQ Insertable Cardiac Monitor is an implantable patient-activated and
automatically-activated monitoring system that records subcutaneous ECG and is indicated in
the following cases:
• Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• Patients who experience transient symptoms such as dizziness, palpitation, syncope, and
chest pain, that may suggest a cardiac arrhythmia
This device has not been specifically tested for pediatric use.
Patient Assistant
The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic.
The Patient Assistant activates the data management feature in the Reveal Insertable Cardiac
Monitor to initiate recording of cardiac event data in the implanted device memory.
Contraindications
There are no known contraindications for the implant of the Reveal LINQ Insertable Cardiac
Monitor. However, the patient’s particular medical condition may dictate whether or not a
subcutaneous, chronically implanted device can be tolerated.
Warnings/Precautions
Reveal LINQ LNQ11 Insertable Cardiac Monitor
Patients with the Reveal LINQ Insertable Cardiac Monitor should avoid sources of diathermy,
high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic
ultrasound, and radiofrequency ablation to avoid electrical reset of the device, and/or
inappropriate sensing as described in the Medical procedure and EMI precautions manual. MRI
scans should be performed only in a specified MR environment under specified conditions as
described in the Reveal LINQ MRI Technical Manual.
Patient Assistant
Operation of the Patient Assistant near sources of electromagnetic interference, such as cellular
phones, computer monitors, etc., may adversely affect the performance of this device.
Potential Complications
Potential complications include, but are not limited to, device rejection phenomena (including
local tissue reaction), device migration, infection, and erosion through the skin.
Medtronic MyCareLinkTM Patient Monitor, Medtronic CareLinkTM Network and CareLinkTM
Mobile Application
Intended Use
The Medtronic MyCareLink Patient Monitor and CareLink Network are indicated for use in the
transfer of patient data from some Medtronic implantable cardiac devices based on physician
instructions and as described in the product manual. The CareLink Mobile Application is
intended to provide current CareLink Network customers access to CareLink Network data via a
mobile device for their convenience. The CareLink Mobile Application is not replacing the full
workstation, but can be used to review patient data when a physician does not have access to a
workstation. These products are not a substitute for appropriate medical attention in the event
of an emergency and should only be used as directed by a physician. CareLink Network
availability and mobile device accessibility may be unavailable at times due to maintenance or
updates, or due to coverage being unavailable in your area. Mobile device access to the Internet
is required and subject to coverage availability. Standard text message rates apply.
Contraindications
There are no known contraindications.
Warnings and Precautions
The MyCareLink Patient Monitor must only be used for interrogating compatible Medtronic
implantable devices.
See the device manual for detailed information regarding the implant procedure, indications,
contraindications, warnings, precautions, and potential complications/adverse events. For further
information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at
www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Medtronic
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Tel: (763) 514-4000
Fax:(763) 514-4879
medtronic.com
Toll-free: 1 (800) 328-2518
(24-hour technical support for
physicians and medical professionals)
UC201608713 EN © Medtronic 2016.
Minneapolis, MN. All Rights Reserved.
Printed in USA. 4/2016